MAUDE Adverse Event Report: S.B.M. SAS Meniscal suture system PULLUP; PULLUP adjustable fixation system for ligament reconstruction in cortical tunnel

Model Number	PULLU01201
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction

• Brand Name: Meniscal suture system PULLUP
• Common Device Name: PULLUP adjustable fixation system for ligament reconstruction in cortical tunnel
• Manufacturer (Section D): S.B.M. SAS; zi du monge; lourdes 65100 ; FR 65100
• MDR Report Key: 50438963
• Report Number: 3012602431-2026-00066
• Device Sequence Number: 13158843
• Product Code: MBI
• UDI-Device Identifier: 03760154007115
• UDI-Public: 03760154007115
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Type of Report: Initial
• Report Date (Section B): 06/07/2025
• Report Date (Section F): 06/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PULLU01201
• Device Lot Number: 250918
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/19/2026
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/25/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/24/2026